Recall Z-1882-2009 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Bard Peripheral Vas
MR Coaxial 10g x 118mm (VC10118MR).
| Date | Aug 26, 2009 (initiated Mar 26, 2009) |
| Status | Terminated |
| Reason | Some Vacora 10G Plastic Coaxial Cannulas may leave a small metal filament in the breast or the sample obtained post procedure. |
| Root cause | Process control |
| Action | Bard Peripheral Vascular, Inc. issued an "Urgent Medical Device Recall Notification" dated March 27, 2009 informing Customers of the affected devices. The firm requested that all affected product be removed and returned along with returning a Recall and Effectiveness Check Form via fax. For further information, contact Bard Peripheral Vascular, Inc. at 1-800-321-4254. |
| Quantity | 1,440 |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082681 | VACORA VACUUM ASSISTED BIOPSY SYSTEM C.R. Bard, Inc., Oct 15, 2008 |